NCT00261365已完成1 期
An Exploratory Study to Determine Potential Predictive Markers of Response and/or Toxicity in Patients With Unresectable Stage III or IV Malignant Melanoma Randomized and Treated With Ipilimumab (MDX-010/BMS-734016) at Two Dose Levels
Bristol-Myers Squibb4 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2005年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Purpose - to identify candidate markers predictive of response and/or serious toxicity to MDX-101 (BMS-734016)
研究概览
简要总结
The purpose of this study is to identify candidate markers predictive of response and/or serious toxicity to BMS-734016 (MDX-010).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic or cytologic diagnosis of unresectable State III or IV malignant melanoma (excluding ocular melanoma); A pre- and post-treatment fresh core or excision tumor biopsy must be provided.
排除标准
- 未提供
研究组 & 干预措施
A1
Active Comparator
干预措施: Ipilimumab (Drug)
A2
Active Comparator
干预措施: Ipilimumab (Drug)
结局指标
主要结局
Purpose - to identify candidate markers predictive of response and/or serious toxicity to MDX-101 (BMS-734016)
时间窗: on a continuous & ongoing basis
次要结局
- Tumor response measured(starting @ wk 12 through wk 24. Those continuing on therapy after wk 24 have tumor responses evaluated every 3 months)
- Safety & tumor response are important secondary objectives. Safety evaluated(on a continuous & ongoing basis)
研究者
研究点 (4)
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